Adtemp™ - ADTEMP Non-Contact IR Therm, - AMERICAN DIAGNOSTIC CORP

Duns Number:108999095

Device Description: ADTEMP Non-Contact IR Therm,

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More Product Details

Catalog Number

433

Brand Name

Adtemp™

Version/Model Number

433

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

a4c0944f-e696-4235-8291-9eafdb345441

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

July 31, 2020

Additional Identifiers

Package DI Number

00634782899783

Quantity per Package

6

Contains DI Package

00634782098407

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack

"AMERICAN DIAGNOSTIC CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2395
2 A medical device with a moderate to high risk that requires special controls. 1769